Label: ASPIRIN ENTERIC COATED, REGULAR STRENGTH- aspirin tablet, coated
- NDC Code(s): 0363-0227-14, 0363-0227-57
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 15, 2020
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- Active ingredient (in each tablet)
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have asthma
you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Other information
black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Principal Display Panel
Compare to Ecotrin® active ingredient††
325 mg / PAIN RELIEVER (NSAID)
**Talk to your doctor or other healthcare provider before using this product for your heart.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Ecotrin®.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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INGREDIENTS AND APPEARANCE
ASPIRIN ENTERIC COATED, REGULAR STRENGTH
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0227 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0227-57 1 in 1 CARTON 12/14/1992 07/20/2020 1 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0363-0227-14 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/14/1992 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/14/1992 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-0227) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-0227) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 MANUFACTURE(0363-0227) , PACK(0363-0227) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(0363-0227)